Glossary · GxP: good practices
Good documentation practice (GDocP)
Also known as: GDocP, Good documentation practices, GDP (documentation)
Good documentation practice (GDocP) is the set of rules for creating, reviewing, correcting and retaining GxP documents and records so that they are attributable, legible, contemporaneous, original and accurate. It is not a separate regulation but is derived from EU GMP Chapter 4 and from the data integrity guidance of MHRA, PIC/S, FDA and WHO.
- GxP
- Data integrity
- Technical documentation
In one sentence
GDocP sets the rules for writing, correcting and keeping GxP records: attributable, legible, contemporaneous, original and accurate, on paper or electronic.
Example
An operator records a weighing result in the batch record at the time of weighing, signs and dates it, and corrects a transcription error with a single line through the wrong value, the correct value, her initials, the date and the reason.
How it applies
- Recording: Entries are made at the time of the activity by the person who performed it, in permanent form, without blank fields left for later.
- Correcting: The original entry stays readable; a correction shows who changed it, when and why. Electronic systems do this through an audit trail.
- Document types: GMP distinguishes instructions (specifications, procedures, master formulae) from records (batch records, logbooks, reports); both are controlled documents with versions, approvals and retention periods.
- Hybrid systems: Where paper and electronic records coexist, the procedure must define which is the original and how the two are linked.
- Technical documentation: GDocP applies to every GxP record, including validation documents and technical writing for SOPs. A revised Chapter 4 was published as a draft in July 2025; check whether the final version has been adopted.
GDocP vs. data integrity
GDocP is the day-to-day practice of recording and correcting. Data integrity is the broader goal that data are complete, consistent and accurate throughout their lifecycle, which also depends on system design, access control and culture. The attributes both refer to are summarized as ALCOA+.